510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KJAClass I

Flask, Tissue Culture

21 CFR 864.2240 / Hematology
FDA source (opens on fda.gov)

KJA is the FDA product code for Flask, Tissue Culture, a class I device type, regulated under 21 CFR 864.2240. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KJA
Device name
Flask, Tissue Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
13
Ingested recalls
1

Clearances, product code KJA

By decision year
13 clearances under product code KJA with a decision year between 1982 and 1997, 1987 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code KJA by decision year
YearClearances
19821
19852
19863
19874
19881
19941
19971

Applicants with the most clearances

Product code KJA
Applicants holding the most 510(k) clearances under product code KJA
ApplicantClearances
American Fluoroseal Corp.2
BD Becton Dickinson Vacutainer Systems Preanalytic2
Nunc, Inc.2
Travenol Laboratories, S.A.2
Corning Costar Corp.1
E.I. Dupont de Nemours & Co., Inc.1
Fenwal Laboratories1
Newport Bio Systems1
Newport Biosystems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 26 companies shown, in name order